Importation Could Endanger Prescription Drug Supply

The safety of the prescription drug supply in the United States could be in jeopardy if Congress passes new legislation that would allow consumers to purchase imported drugs from 26 different countries without the validation of their safety.

As part of a political deal brokered recently during the congressional debate over Medicare, the leadership promised a vote in the U.S. House soon on legislation to allow Americans to “reimport” their medicines.

Reimportation would allow American consumers to purchase prescription drugs that have been manufactured in the United States and shipped to Canada where they are sold under Canada’s system of price controls.

While the House and Senate have each passed reimportation legislation in three of the last four years, this time it comes with a new twist. Under the new proposed legislation, reimported drugs could come from 26 different countries and would be permitted without the safety approval of the Department of Health and Human Services.

Allowing American consumers to purchase drugs from all these countries where the origin of the drugs is uncertain is really importation, not reimportation. Importation is even more dangerous because the original drugs may not have come from the United States.

Until now, department officials have blocked the implementation of such legislation, citing concerns over their ability to protect the safety of the nation’s drug supply coming from Canada and the lack of cost savings that would result.

Ten of the last eleven Commissioners of the Food and Drug Administration, the current Secretary of the Department of Health and Human Services Tommy Thompson, and former HHS Secretary Donna Shalala all have opposed reimportation.

But the newest proposed legislation would omit the clause that granted authority to these officials in decisions to implement the law.

That is a big mistake and one that could be dangerous for American consumers.

The HHS officials have opposed reimportation because of the risks associated with mishandling, mislabeling, improper storage, ineffective product recalls, and expiration date violations.

Some also expressed concern about the potential for opportunists to manufacture and sell counterfeit drugs. The more times prescription drugs change hands, the more likely it is that the criminal element can take advantage of the system.

At recent House Energy and Commerce Committee hearings on counterfeit drugs, Ms. Elizabeth Durant, Director of Trade Programs at the Bureau of Customs and Border Protection, said, “Thousands of packages, particularly in the mail, are found to contain illegal and unapproved pharmaceuticals?a disturbing trend is the increase in bulk shipments through the mail, indicating that these products could be making their way to pharmaceutical shelves.”

Ms. Durant went on to discuss the specific defects her agency found with confiscated prescription drugs that had been sent through international mail. “We have also found that a significant number of [confiscated drugs] do not contain an active ingredient, but merely contain substances such as starch or sugar. Other problems include expired materials, unapproved products, improper usage instructions, and products made in facilities not under proper regulation,” said Durant.

Even the Canadian government admitted that they could not ensure that the drugs being shipped to the United States are safe.

In early May, Health Canada issued an official statement clarifying that while they would take responsibility to ensure that prescription drugs coming into Canada were safe, they could not guarantee the safety of drugs exported to the United States or other countries.

That should be a sobering warning to those who believe prescription drugs bought from Canada are just as safe as those purchased from U.S. pharmacies.

There is also reason to believe that reimportation would not reduce the price of prescription drugs in the U.S., which is the primary motivation of those who support the practice.

It is unlikely that pharmaceutical companies would continue to provide Canada and other countries with deeply discounted drugs if reimportation were allowed. A more likely result is that the pharmaceutical companies would start demanding more money for their prescription drugs when negotiating with foreign governments.

And the middlemen, wholesalers and importers, are likely to garner a significant cut as well.

There is very little chance, based on economic principles, that prescription drugs would, in fact, become cheaper in the U.S. if reimportation were allowed.

From both a safety and economic standpoint, importation of prescription drugs is a lose-lose proposition for the American consumer and should be shot down.

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The safety of the prescription drug supply in the United States could be in jeopardy if Congress passes new legislation that would allow consumers to purchase imported drugs from 26 different countries without the validation of their safety.

As part of a political deal brokered recently during the congressional debate over Medicare, the leadership promised a vote in the U.S. House soon on legislation to allow Americans to “reimport” their medicines.

Reimportation would allow American consumers to purchase prescription drugs that have been manufactured in the United States and shipped to Canada where they are sold under Canada’s system of price controls.

While the House and Senate have each passed reimportation legislation in three of the last four years, this time it comes with a new twist. Under the new proposed legislation, reimported drugs could come from 26 different countries and would be permitted without the safety approval of the Department of Health and Human Services.

Allowing American consumers to purchase drugs from all these countries where the origin of the drugs is uncertain is really importation, not reimportation. Importation is even more dangerous because the original drugs may not have come from the United States.

Until now, department officials have blocked the implementation of such legislation, citing concerns over their ability to protect the safety of the nation’s drug supply coming from Canada and the lack of cost savings that would result.

Ten of the last eleven Commissioners of the Food and Drug Administration, the current Secretary of the Department of Health and Human Services Tommy Thompson, and former HHS Secretary Donna Shalala all have opposed reimportation.

But the newest proposed legislation would omit the clause that granted authority to these officials in decisions to implement the law.

That is a big mistake and one that could be dangerous for American consumers.

The HHS officials have opposed reimportation because of the risks associated with mishandling, mislabeling, improper storage, ineffective product recalls, and expiration date violations.

Some also expressed concern about the potential for opportunists to manufacture and sell counterfeit drugs. The more times prescription drugs change hands, the more likely it is that the criminal element can take advantage of the system.

At recent House Energy and Commerce Committee hearings on counterfeit drugs, Ms. Elizabeth Durant, Director of Trade Programs at the Bureau of Customs and Border Protection, said, “Thousands of packages, particularly in the mail, are found to contain illegal and unapproved pharmaceuticals?a disturbing trend is the increase in bulk shipments through the mail, indicating that these products could be making their way to pharmaceutical shelves.”

Ms. Durant went on to discuss the specific defects her agency found with confiscated prescription drugs that had been sent through international mail. “We have also found that a significant number of [confiscated drugs] do not contain an active ingredient, but merely contain substances such as starch or sugar. Other problems include expired materials, unapproved products, improper usage instructions, and products made in facilities not under proper regulation,” said Durant.

Even the Canadian government admitted that they could not ensure that the drugs being shipped to the United States are safe.

In early May, Health Canada issued an official statement clarifying that while they would take responsibility to ensure that prescription drugs coming into Canada were safe, they could not guarantee the safety of drugs exported to the United States or other countries.

That should be a sobering warning to those who believe prescription drugs bought from Canada are just as safe as those purchased from U.S. pharmacies.

There is also reason to believe that reimportation would not reduce the price of prescription drugs in the U.S., which is the primary motivation of those who support the practice.

It is unlikely that pharmaceutical companies would continue to provide Canada and other countries with deeply discounted drugs if reimportation were allowed. A more likely result is that the pharmaceutical companies would start demanding more money for their prescription drugs when negotiating with foreign governments.

And the middlemen, wholesalers and importers, are likely to garner a significant cut as well.

There is very little chance, based on economic principles, that prescription drugs would, in fact, become cheaper in the U.S. if reimportation were allowed.

From both a safety and economic standpoint, importation of prescription drugs is a lose-lose proposition for the American consumer and should be shot down.